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Latest PriceChg%ChgVolumeTurnoverOpenPre CloseHighLowMarket CapFloat CapSharesShs Float5D %Chg10D %Chg20D %Chg60D % Chg120D %Chg250D %Chg% Year-to-dateDiv YieldTTMTurnover RatioP/E (TTM)P/E (Static)AmplitudeIndustry
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DVAX240517P13000
- 3.51
- 0.000.00%
15min DelayTrading May 9 15:08 ET
0.00High0.00Low
0.00Open3.51Pre Close0 Volume2 Open Interest13.00Strike Price0.00Turnover437.64%IV-8.25%PremiumMay 17, 2024Expiry Date1.91Intrinsic Value100Multiplier2DDays to Expiry1.60Time Value100Contract SizeAmericanOptions Type-0.5987Delta0.0961Gamma3.93Leverage Ratio-0.3420Theta-0.0006Rho-2.35Eff Leverage0.0036Vega
Intraday
- 5D
- 1D
News
Dynavax Down 5% on FDA Complete Response Letter for Heplisav-B for Hemodialysis
UPDATE 1-US FDA Declines to Approve Expanded Use of Dynavax's Hepatitis B Vaccine
Dynavax Application for Hepatitis B Treatment Ruled Insufficient by FDA
By Denny Jacob Dynavax disclosed that the Food and Drug Administration has ruled its application for its hepatitis B vaccine treatment didn't provide sufficient data to support the full evaluation of
Express News | Shares of Dynavax Down 7.9% Premarket After FDA Declines Expanded Use of Its Hepatitis B Vaccine in Dialysis Patients
Express News | FDA Issued Complete Response Letter To Dynavax Saying SBLA For Four-Dose HEPLISAV-B Regimen Did Not Provide Sufficient Data To Support Full Evaluation Of Effectiveness Or Safety
Express News | Dynavax Technologies:Crl Does Not Affect Approval From European Commission in Oct 2023 for 4-Dose Heplisav-B Regimen for Adult Hemodialysis Population
Comments
$Dynavax Technologies(DVAX.US$ Reuters· 1 min ago
Dynavax: Crl States Application Did Not Provide Sufficient Data to Support Full Evaluation of Effectiveness or Safety of 4-Dose Regimen of Heplisav-B
Dynavax: Crl States Application Did Not Provide Sufficient Data to Support Full Evaluation of Effectiveness or Safety of 4-Dose Regimen of Heplisav-B
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See summary 👇
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
7
2
The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
10
1
Dynavax Technologies' long-term performance remains strong despite a recent 8.6% pullback. The company's profit growth is commendable, and its 15% annual gain, though below market return, surpasses its 5-year average, suggesting a successful strategy attracting new investors.
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